Proactive Breastfeeding Support in First Time Mothers

Not Applicable

• Conditions: Breastfeeding
• Interventions: Behavioral: Breastfeeding support

• Registration Number: NCT01998087
• Lead Sponsor: University Hospital of Split

Brief Summary

In Croatia, between 95% and 99% of mothers initiate breastfeeding, but by 3 months a third have stopped, and by six months only half are still providing any human milk for their babies. Exclusive breastfeeding rates are even lower, with only about 9% of Croatian mothers exclusively breastfeeding at 6 months, despite the WHO recommendation of 6 months of exclusive breastfeeding. Currently, in Croatia, no breastfeeding information or other pregnancy and parenting related written information is routinely provided to expectant couples. In our study we would like to find out whether providing written breastfeeding information in pregnancy and breastfeeding focused support phone calls during pregnancy and after the birth of the baby result in better outcomes than providing general pregnancy/parenting information and support phone calls. This will be tested by randomising women, attending their primary health care provider for routine antenatal visits between 20 and 32 weeks, to an intervention focused on promoting and supporting breastfeeding, to an intervention focused on general pregnancy and parenting issues, and to a non-intervention control group. Women will be followed-up for 6 months after the birth of their baby and data will be collected at 3 and 6 months on breastfeeding rates, breastfeeding self-efficacy, breastfeeding difficulties, social support and attitudes toward infant feeding.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2013-11-27
• Study First Posted: 2013-11-28
• Study Start: 2014-06
• Primary Completion: 2017-06
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-12
• Last Update Posted: 2018-10-15
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• expectant women, between 20 and 32 weeks gestation, attending any of 6 pre- determined antenatal clinics
• primigravidae
• singleton pregnancy
• can read and write Croatian
• resides in Croatia or plans to stay in Croatia at least 12 months following the birth

Exclusion Criteria

• multigravidae
• women expecting twins/multiples
• refuses to participate
• inability to communicate in Croatian by phone
• planning to leave the County of Split Dalmatia within a year of giving birth
• severe maternal psychiatric or medical problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breastfeeding support	Breastfeeding support	A breastfeeding brochure will be distributed to expectant mothers from 20 weeks gestation during their regular antenatal visit. This will be followed 2 weeks later by a phone call offering clarification/explanation of the brochure. Three standardized phone calls, offering breastfeeding support, will be conducted at 2,6 and 10 weeks following birth of the baby.
General Support	Breastfeeding support	The active control group of mothers will receive a brochure in pregnancy covering general pregnancy and parenting issues and follow-up phone calls but breastfeeding issues will not be specifically addressed. If a mother raises any breastfeeding issue she will be referred to appropriate support.

Primary Outcome Measures

Name	Time	Method
Exclusive breastfeeding	3 months

Secondary Outcome Measures

Name	Time	Method
Any breastfeeding	3 & 6 months

Trial Locations

Locations (1)

Cito Obstetrics and Gynaecology Clinic; 🇭🇷 Split, Outside AUS, Croatia